Prenatal Diagnosis
Conditions
Keywords
fetal pain, fetal analgesia
Brief summary
The fetus may be exposed during pregnancy to nociceptive stimuli because of fetal pathology (e.g., malformation) or a diagnostic or therapeutic procedure. To date, there is very little data and no consensus on fetal analgesia. The aim of the investigators study is to evaluate the pharmacokinetics of Sufentanil after intra amniotic injection.
Interventions
DRUGSufentanil
intra-amniotic injection of 10 micrograms of Sufentanil
Sponsors
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Termination of pregnancy for fetal malformation * Gestational age \> 24 weeks of gestation
Exclusion criteria
* Multiple pregnancy * Allergy or contraindication to sufentanil * Morphinic addiction * fetal gastroschisis, omphalocele or swallowing disorder * maternal cardiac or respiratory distress
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fetal plasma concentrations | at 30 minutes after intra-amniotic injection | fetal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal plasma concentrations | at 30 minutes and at 1, 2, 4, 8, 24 hours after intra-amniotic injection | Maternal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector) |
| amniotic fluid concentrations | Immediately within 5 min after intra-amniotic injection | The amniotic fluid concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector) |
Countries
France
Outcome results
None listed